March 27, 2012

Judge Blocks Shipment of 'Unapproved' Drug Used in Lethal Injections

A District of Columbia federal judge today ruled in favor of a group of death row inmates seeking a court order to stop the shipment of a "misbranded and unapproved" drug used in state legal injections.

U.S. District Judge Richard Leon
found (PDF) that the Food and Drug Administration acted "arbitrarily and capriciously and abused its discretion" in approving shipments of sodium thiopental, commonly known as thiopental, which is used to induce general anesthesia during the lethal injection process.

The FDA had argued that it allowed the shipments out of deference to law enforcement officials when it came to lethal injections. Leon rejected that argument, writing that federal law clearly requires the FDA to review and approve all drugs.

“In the final analysis, the FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle,” Leon wrote. “How utterly disappointing!”

Lead counsel for the plaintiffs, Bradford Berenson of Sidley Austin in Washington, said in a phone interview today that Leon’s decision was “gratifying.”

“He saw that the agency was behaving in a clearly unlawful way and took steps to make sure that even the most despised members of society got the benefit of the protections that Congress put in place,” he said.

The FDA, through a spokeswoman, declined to comment.

The inmates, who are in jails in Arizona, California and Tennessee, sued the FDA in U.S. District Court for the District of Columbia in February 2011, accusing officials of approving shipments of thiopental without first reviewing and approving the drug in accordance with the federal Food, Drug, and Cosmetic Act.

Leon wrote that while thiopental was produced for years in the United States and was widely used at one point by anesthesiologists, it was never formally approved by the FDA.

After U.S. companies stopped producing thiopental in 2009, states began buying it from producers overseas. The foreign versions of the drug, like the domestic ones, never underwent FDA review, Leon wrote.

The inmates claimed in their complaint that by allowing the shipments of an "unapproved" and “misbranded” drug, there was a risk that the drugs could fail to properly anesthetize them. Without anesthesia, the inmates could be at risk of facing “conscious suffocation, pain and cardiac arrest” during the rest of the lethal injection process.

The FDA countered that it had discretion to choose whether to initiate an enforcement action under the Food, Drug, and Cosmetic Act. The government also argued that the inmates had failed to prove a connection between the FDA’s decision not to review the drugs before allowing the import and the risk of suffering during the lethal injection.

Leon found that the Food, Drug, and Cosmetics Act didn’t give the FDA discretion to allow shipments of the unapproved drug. He wrote that the FDA was ignoring a mandatory administrative directive, not making a decision within its discretion about enforcement.

Leon wrote that the FDA acted “arbitrarily and capriciously and have abused their discretion.” He found that the FDA’s decision had put the inmates at a real risk of injury.

“Even when in the correct hands, prisoners on death row have an unnecessary risk that they will not be anesthetized properly prior to execution,” Leon wrote. “Further, defendants' actions also create a slippery slope that other unapproved foreign drugs may be allowed to enter into the United States to the detriment of the general public.”